Effective Date: May 1, 2012

Effective Date: Version: 1 May 1, 2012 Page: 1 of 10 TITLE: SAF-310-1, BIOSAFETY LEVEL 3 MANUAL 1. PURPOSE 1.1. The purpose of this program is to p...
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Effective Date: Version: 1 May 1, 2012

Page: 1 of 10

TITLE: SAF-310-1, BIOSAFETY LEVEL 3 MANUAL

1. PURPOSE 1.1. The purpose of this program is to provide a set of minimum requirements for individuals working in biosafety level 3 labs (both animal and non-animal). This manual is written as a supplement to the Emory University Biosafety Manual and builds upon the concepts and requirements set forth in that manual. 2. SCOPE 2.1. The requirements of the Biosafety Level 3 (BSL-3) Manual are applicable to all Emory University personnel and graduate students working in Emory BSL-3 or animal BSL-3 (ABSL-3) facilities (to be referred to as facilities through the rest of this manual) on the Emory University Campus. All others must make special arrangements with the facility manager for entry. 2.2. All of the forms referenced in this manual are meant to serve as examples. Personnel are not required to use them but they include the minimum requirements in terms of documentation. 3. REFERENCES 3.1. Emory University Environmental Health and Safety Office Website 3.2. Biosafety in Microbiological and Biomedical Laboratories, 5th Edition 3.3. Emory University Biosafety Manual 3.4. Guidelines for the Safe Use of Sharps 3.5. BSL-3 / ABSL-3 Facility Initial Training Checklist 3.6. BSL-3 / ABSL-3 Facility Annual Renewal Training Checklist 3.7. BSL-3 / ABSL-3 Facility Entry / Exit Log 3.8. BSL-3 / ABSL-3 Facility Visitor Checklist 3.9. BSL-3 / ABSL-3 Weekly Monitoring Form 3.10. BSL-3 Facility Self-Inspection Form 3.11. ABSL-3 Facility Self-Inspection Form 3.12. Corrective Action Plan Form 3.13. Critical Event Preparedness and Response Website 4. RESPONSIBILITIES 4.1. Biosafety Officer (BSO) / Environmental Health and Safety Office (EHSO) 4.1.1. Reviews any deviations from the recommendations in this manual. 4.1.2. Conducts weekly monitoring (if designated as responsible person in facility). 4.1.3. Works with facility manager, principal investigators (PIs), the Division of Animal Resources (DAR), and facilities (as applicable) to coordinate facility preventative maintenance.

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TITLE: SAF-310-1, BIOSAFETY LEVEL 3 MANUAL 4.1.4. Works with the facility manager to conduct annual facility validation. 4.1.5. Oversees large space decontamination procedures when needed. 4.1.6. Maintains training records. 4.2. Facility Manager 4.2.1. Oversees day-to-day operations of facility which include: monitors laboratory practices, identifies problems, and reports adverse events and deviations from policies. 4.2.2. Manages access to the facility (training, visitors, mentoring, etc.). 4.2.3. Conducts weekly monitoring (if designated as responsible person in facility). 4.2.4. Conducts annual self-inspection. 4.2.5. Works with EHSO, PIs, DAR and Facilities (as applicable) to coordinate facility preventative maintenance. 4.2.6. Works with EHSO to conduct annual facility validation. 4.2.7. Maintains training records. 4.3. Principal Investigators (PI) 4.3.1.

Ensures that they and their lab personnel working in facilities meet occupational health and training requirements.

4.3.2.

Ensures that they and their lab personnel adhere to all work practices, emergency procedures, and administrative procedures listed in this manual and facility specific standard operating procedures (SOPs).

4.4. Facility Lab and Animal Care Personnel 4.4.1. Ensures they meet occupational health and training requirements. 4.4.2. Adheres to all work practices, emergency procedures, and administrative procedures listed in this manual and facility specific SOPs. 4.5. Facility Management Staff 4.5.1. Coordinates with facility manager, EHSO, PIs, and DAR (as applicable) to conduct preventative maintenance. 4.5.2. Immediately responds to emergency facility issues. 5. FACILITY ACCESS REQUIREMENTS 5.1. In order to conduct laboratory work in facilities, the following requirements are met. These requirements may be subject to periodic review. Access to facilities is a privilege and may be revoked if University and facility policies and procedures are not upheld. 5.2. Individuals under the age of 18 are prohibited from entering facilities. 5.3. Protocol Approval Before work is conducted in facilities, it is approved by applicable Emory committees: Institutional Health and Biosafety Committee (IHBC), Institutional

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TITLE: SAF-310-1, BIOSAFETY LEVEL 3 MANUAL Animal Care and Use Committee (IACUC). During the protocol approval process, EHSO general training status and occupational health requirements are reviewed. 5.4. Facility Director Approval Once protocols are approved by the appropriate Emory committees, PIs gain approval from the appropriate facility director (or other person authorized to allocate space) to conduct work in the specific facility. Approval may be based on space availability and protocol requirements. 5.5. Occupational Health Requirements Facility access may be conditional on occupational health requirements such as respiratory clearance and vaccinations. Annual occupational health evaluations may be required. Additional evaluations and vaccinations may be required in the event that hazards change in the facility. 5.6. Training Requirements Personnel listed on the protocol approved to work in a facility are trained according to the Training section of this manual. Training is reviewed annually. 6. TRAINING 6.1. EHSO General Training University PIs and lab personnel working in an Emory laboratory are required to complete the applicable EHSO training as described in the Emory University Biosafety Manual. 6.2. Facility Specific Training 6.2.1. In order to gain full, un-escorted access to a facility, lab personnel complete training as described below: 6.2.1.1. PI ensures lab personnel demonstrate proficiency at biosafety level 2 (BSL2) and verbal competence to communicate during an emergency. 6.2.1.2. The candidate successfully completes the Section I of the BSL-3 / ABSL-3 Facility Initial Training Checklist. Each item is evaluated, with the date and initial of the PI. 6.2.1.3. Provisional candidates are assigned an experienced mentor to train them on how to work safely in the facility for a recommended period of two weeks. 6.2.1.4. During the provisional access period, the designated mentor trains and evaluates the provisional candidate on the items listed in Section II of the BSL-3 / ABSL-3 Facility Initial Training Checklist. Each item is evaluated, with the date and initial of the mentor. 6.2.1.5. The provisional candidate is considered for full, unescorted access after a recommended provisional access period and the successful completion of Sections I and II of the BSL-3 / ABSL-3 Facility Initial Training Checklist. To approve full, unescorted access the designated mentor and PI / facility manager fill out Section III of the BSL-3 / ABSL-3 Facility Initial Training Checklist.

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TITLE: SAF-310-1, BIOSAFETY LEVEL 3 MANUAL 6.2.1.6. All facility users renew full access annually by completing Sections I and II of the BSL-3 / ABSL-3 Facility Annual Renewal Training Checklist. To renew full access, the PI / facility manager fills out Section III of the BSL-3 / ABSL-3 Facility Annual Renewal Training Checklist. 6.2.1.7. The above training steps are documented and retrievable upon request by an auditor. 7. ENTRY / EXIT PROCEDURES 7.1. Personnel entering and exiting the facility is recorded either by electronic key card systems or a handwritten log such as the BSL-3 / ABSL-3 Facility Entry / Exit Log. 7.2. General Entry Procedures Prior to entry to the laboratory, observe posted laboratory signage for entry requirements and laboratory hazards. Check the airflow monitors at the entry door to ensure that air moves from the corridor into the laboratory. If the flow is incorrect, contact the facility manager or other responsible person immediately and do not enter. Enter the laboratory by adhering to facility specific SOPs. 7.3. General Exit Procedures Adhere to facility specific SOPs to remove personal protective equipment (PPE) appropriately and wash hands while exiting the laboratory. Also, adhere to facility specific SOPs when removing items from the facility. 7.4. Access to Facilities 7.4.1. Refer to the following table for access restrictions to facility: Individual Approved Level 3 User

Access Level Full unescorted access

Provisional Level 3 Candidate

No access unless with designated mentor

EHSO

No access unless with designated escort No access unless with designated escort No access unless with designated escort No access unless with designated escort

Maintenance Staff Approved Scientific Visitors Contractors / Vendors

Documentation Required All sections of: • BSL-3 / ABSL-3 Facility Annual Renewal Training Checklist; or • BSL-3 / ABSL-3 Facility Initial Training Checklist Section I of BSL-3 / ABSL-3 Facility Initial Training Checklist BSL-3 / ABSL-3 Facility Visitor Checklist BSL-3 / ABSL-3 Facility Visitor Checklist BSL-3 / ABSL-3 Facility Visitor Checklist BSL-3 / ABSL-3 Facility Visitor Checklist

8. WORK PRACTICES 8.1. In addition to the work practices listed in the Emory University Biosafety Manual, adhere to the following procedures when working in facilities.

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TITLE: SAF-310-1, BIOSAFETY LEVEL 3 MANUAL 8.2. Two Person Rule Facilities require that no one person works in the facility alone. This is to ensure that at least two people are present in case of emergency. Exceptions may occur in limited circumstances. In those instances warranting an exception, each facility must have developed a site specific plan that has been reviewed and approved in advance by the facility and EHSO. 8.3. Autoclave Use Autoclaves are validated, using a biological indicator, at least weekly. In many cases, it may be necessary to validate each load. Autoclave validation is documented. 8.4. Personal Electronic Devices Personnel are prohibited from bringing personal electronic devices, such as cell phones, iPods, and MP3 players, into the facility. 8.5. Safe Sharps The use of sharps in facilities is strongly discouraged. Personnel are encouraged to use sharp-safe systems. Whenever possible, sharp objects should be replaced with blunt objects. All disposable sharps are one time use only. Refer to the Guidelines for the Safe Use of Sharps for more information on safe sharp work practices. 8.6. Glassware The use of glassware in facilities is minimized. Whenever possible, glassware is avoided and substituted with plastic ware in facilities. Broken glassware should be picked up with a mechanical device (ex: tongs or a dustpan and brush). Never handle broken glass directly with hands. 8.7. Minimization of Aerosol Production and Release 8.7.1. Manipulate biohazardous material inside a biosafety cabinet (BSC) to reduce the risk of aerosol release. The following guidelines minimize the production of aerosols: 8.7.1.1. Pipetting: Do not force liquid out of the pipette tip. Allow liquid from the pipette to flow slowly down the side of tubes or flasks. Use cotton-plugged pipettes. 8.7.1.2. Mixing: Operate mixing equipment inside a BSC. Do not mix by sucking and blowing with a pipette. 8.7.1.3. Transfer Loops: Use an enclosed micro-incinerator for sterilization inside a BSC. Use disposable loops when possible. 8.7.1.4. Syringes and Needles: Fill syringes carefully so that bubbles are not produced. Use luer lock syringes. 8.7.1.5. Vacuum Equipment: Protect vacuum equipment with a high efficiency particulate air (HEPA) filter and place disinfectant in the overflow flask. 8.7.1.6. Tube Selection: It is strongly encouraged, when working with liquids, to use screw-cap tubes rather than flip-cap tubes. 8.8. Procedures for Centrifugation

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TITLE: SAF-310-1, BIOSAFETY LEVEL 3 MANUAL 8.8.1. Centrifugation is performed using lidded centrifuge safety buckets or in sealed ultracentrifuge rotors. As microcentrifuges do not have removable safety buckets, these are operated inside a BSC. When centrifuging in facilities: 8.8.1.1. Load samples into the safety bucket or rotor inside the BSC. 8.8.1.2. Seal the safety bucket or rotor and wipe down with disinfectant. 8.8.1.3. Change outer gloves. 8.8.1.4. Transport the sealed safety bucket or rotor from the BSC to the centrifuge. 8.8.1.5. After the run is complete allow 2-5 minutes for aerosols to settle in case of a spill inside. 8.8.1.6. Transport the sealed safety bucket or rotor to the BSC before opening. 8.8.1.7. Decontaminate the rotor or safety bucket inside the BSC before returning it to the centrifuge. 8.9. Housekeeping 8.9.1. Decontamination of Work Surfaces / Equipment 8.9.1.1. Decontaminate work surfaces and equipment when procedures are complete, after a spill, and after a potential contamination. Work surfaces and equipment are decontaminated at minimum at the end of each work day. Use a chemical disinfectant appropriate for the agent used and allow an appropriate contact time. 8.9.2. Decontamination of Large Spaces 8.9.2.1. Large space decontamination (i.e. room or facility decontamination) is performed by a specialist with appropriate training and PPE and in conjunction with EHSO. If large space decontamination is needed in a facility, contact the EHSO. 8.9.3. Floor Cleaning 8.9.3.1. With the exception of animal facilities, the facility manager coordinates floor cleaning. 9. PERSONAL PROTECTIVE EQUIPMENT 9.1. Adhere to facility specific SOPs. At minimum, personnel working in a facility wear a solid front lab gown and gloves. 9.2. Reusable laboratory protective clothing is autoclaved out of the facility prior to laundering. Laboratory clothing is laundered by Emory or an Emory approved vendor. Washing laboratory protective clothing at home is strictly prohibited. Non-reusable PPE is disposed of as biohazardous waste. 10. REMOVAL OF ITEMS FROM THE FACILITY 10.1. Waste WASTE TYPE

DISPOSAL METHOD

Biological

Biohazard containers, lined with biological waste trash bags, are present throughout the facility for the disposal of biological waste (other than sharps).

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TITLE: SAF-310-1, BIOSAFETY LEVEL 3 MANUAL WASTE TYPE

DISPOSAL METHOD Sharps containers are available at the point of generation. Collection containers remain closed when not in use and are disposed of when 3/4 full. 1. Solid Waste Treatment / Removal: Autoclave the bag of waste and remove it from the facility. Place the autoclaved waste in the site specific container for vendor pickup. 2. Liquid Waste Treatment / Removal: Liquid waste may be decontaminated two different ways. It may be autoclaved following site specific validated procedures or treated with an approved disinfectant for the appropriate contact time. After decontamination, liquid waste may be discarded by pouring it down the sink.

Chemical

The outside of chemical waste containers are sprayed with a disinfectant appropriate to the agents used in the lab and allowed appropriate contact time before being wiped down and removed from the lab. Chemical wastes are disposed of through EHSO. Refer to the Waste page on the EHSO website for more information.

Radioactive

Contact EHSO for specific disposal procedures.

Mixed

Mixed waste contains at least two of the following components: biohazardous waste, chemical waste, radioactive waste. Consult with EHSO for specific disposal instructions for mixed waste accumulated in facilities.

10.2. Equipment and Other Non-Biological Material Decontaminate all equipment and non-biological material before removing it from the facility. In most cases, equipment and non-biological material are autoclaved out of the facility. Whenever possible, researchers should select equipment and material that can withstand being autoclaved out of the facility. In the event that the equipment or material cannot be autoclaved, follow decontamination procedures that are appropriate for the facility, agent, and equipment. Laboratory personnel are advised to electronically scan or fax documents/notes inside the facility as lab notebooks will be damaged when autoclaved. Laboratory documents are not removed from the laboratory unless they have been autoclaved. 10.3. Research Biological Material 10.3.1. Research biological material needing to be removed from the facility should be explained in the Biosafety Protocol and approved by the IHBC. Research biological material may be removed from the facility after adhering to the following procedure inside the BSC: 10.3.1.1. If transporting lidded containers, ensure that they are tightly sealed. If transporting plates, seal the edges (ex: parafilm). 10.3.1.2. Wipe the outside of each tube or plate with an appropriate disinfectant. 10.3.1.3. Place the tubes or plates in a leak-proof secondary container. 10.3.1.4. Close the secondary container.

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TITLE: SAF-310-1, BIOSAFETY LEVEL 3 MANUAL 10.3.1.5. Wipe the outside of the secondary container with an appropriate disinfectant and remove from the BSC. 10.3.1.6. Prior to exiting the facility, spray the outside of the secondary container with an appropriate disinfectant. 10.3.1.7. In the exit area (i.e. anti-room, pass through area) place the secondary container into a tertiary container baring the biohazard symbol and close it. A sealed biohazard bag is an example of an appropriate tertiary container. 10.3.1.8. Exit the facility following facility specific SOPs. 11. EMERGENCY RESPONSE PROCEDURES 11.1. Reporting Adverse Events and/or Injuries/Exposures Adverse events and/or injuries/exposures are reported immediately per facility specific procedures. 11.2. “Just in Time” Guide to Campus Emergencies “Just in Time: A Guide to Campus Emergencies” is posted near laboratory exits in facilities. It provides general guidance for a variety of campus emergencies. An electronic version is available on the Critical Event Preparedness and Response Website. 11.3. Facility Specific Emergency Plans 11.3.1. In addition to the instructions provided in the “Just in Time” guide, each facility develops and maintains facility specific emergency plans. At a minimum, these plans include the following: 11.3.1.1. Emergency contact and phone numbers 11.3.1.2. A communication system 11.3.1.3. Plans for the following emergencies 11.3.1.3.1. Medical emergencies 11.3.1.3.2. Fire emergencies 11.3.1.3.3. Natural disasters 11.3.1.3.4. Utility failures 11.3.1.3.5. Human generated disasters (ex: explosions, threats) 11.3.1.4. Emergency plan drills 12. ADMINISTRATIVE PROCEDURES 12.1. Facility-Specific SOPs 12.1.1. Facilities develop their own SOPs for processes specific to their facility design, agents used, and programs. These include but are not limited to: facility emergency plans, entry, exit, and designating who is responsible for allocating space inside the facility. 12.1.2. Facility specific SOPs are reviewed and revised as needed by the facility, and are made available to facility personnel.

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TITLE: SAF-310-1, BIOSAFETY LEVEL 3 MANUAL 12.1.3. The facility specific SOPs are also made available for EHSO to review. 12.2. Facility Maintenance Program 12.2.1. In order to maintain a safe and functional facility, each facility undergoes various types of inspection/maintenance procedures throughout the year. The table below lists and describes each procedure in the order that they occur. TYPE

OCCURRENCE DESCRIPTION

Monitoring

Weekly

A designated, trained and responsible person (ex: facility manager or EHSO personnel) conducts and documents site specific weekly monitoring inspections. See BSL-3 / ABSL-3 Weekly Monitoring Form for minimum items that are included in the weekly inspection.

SelfInspection

Annually

Each year, the facility manager conducts a self-inspection of the facility using the BSL-3 Facility Self-Inspection Form or the ABSL3 Facility Self-Inspection Form. After completion of selfinspection, the facility manager submits a Corrective Action Plan Form (CAP) to EHSO (following instructions on the form).

EHSO Inspection

Annually

After submission of CAP by facility manager to EHSO, EHSO conducts an inspection of the facility using the BSL-3 Facility SelfInspection Form or the ABSL-3 Facility Self-Inspection Form.

Facility Preventative Maintenance

Recommended The Self-Inspection and EHSO Inspection are designed to highlight Annually any issues (work practices, facility maintenance, engineering controls, etc.) that need to be resolved. Ideally, resolution of these issues along with preventative maintenance is conducted during an annual facility shutdown. See Facility Maintenance Items section below for specific details. The facility preventative maintenance is coordinated with the facility manager, EHSO, PIs, facilities personnel, and DAR (if applicable). Animal facilities offer more challenges than non-animal facilities. When possible, laboratory work is suspended for a period of time and the facility is decontaminated (using an appropriate method) in order for preventative maintenance to occur.

Facility Validation

Recommended After the Facility Preventative Maintenance is completed, a facility Annually validation is performed by EHSO and the facility manager to ensure that the lab is ready to be re-commissioned.

12.3. Facility Maintenance Items 12.3.1. The following items are essential for preventative facility maintenance and are coordinated by the facility manager, PI, EHSO and facilities personnel. 12.3.2. Prior to purchasing and installing equipment inside level three facilities, ensure that the equipment specific maintenance or certification vendor will agree to enter the facility to provide service. 12.3.3. Equipment Validation / Testing / Certification

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TITLE: SAF-310-1, BIOSAFETY LEVEL 3 MANUAL 12.3.3.1. Biological Safety Cabinets (BSC): BSCs are certified annually. Facility managers are responsible for coordinating BSC certification with approved a vendor approved by Emory University. 12.3.3.2. Chemical Fume Hoods (CFH): CFHs are certified annually. Facility managers are responsible for coordinating CFH certification with EHSO. 12.3.3.3. Autoclaves: Facility managers are responsible for coordinating autoclave inspection and maintenance per manufacturer’s recommendations. 12.3.3.4. Other Equipment: Other equipment (such as centrifuges, freezers, etc) may require maintenance or certification and should be coordinated by the facility manager. 12.3.4. Facility HEPA Filter Changes (if applicable) 12.3.5. Air Pressure Differential Validation 12.3.6. Electronic Control Calibrating 13. PROGRAM EVALUATION 13.1. The written Biosafety Level 3 Manual shall be re-evaluated at least annually and revised if necessary. 14. RECORD KEEPING 14.1. Training records are retained by the Facility Manager and EHSO and available through EHSO.